FDA MOVES TO SPEED NEW DRUG APPROVALS

The FDA announced steps to accelerate
the earliest phases of clinical research for
important new medicines to treat such
life-threatening conditions as cancer, heart
disease, and neurologic disorders.

The new approach will help more researchers
conduct earlier, more informed
studies of promising treatments so that
patients have more rapid access to safer
and more effective drugs.

Officials at the Pharmaceutical Research
and Manufacturers of America
(PhRMA) praised the FDA for taking action
that may significantly reduce the time
required to bring new-generation drugs to
the market. PhRMA President and Chief
Executive Officer Billy Tauzin hailed the
FDA's action as a move that will "improve
and accelerate the research and development
of new medicines that can help
patients suffering from potentially deadly
diseases live longer, healthier lives."

According to Tauzin, "too many times
promising new treatments fall through the
cracks because the process involved?can
be arduous and full of red tape." Speeding
the clinical review process will "encourage
rapid delivery of innovative treatments for
patients who don't have time on their
side," he said.